Evaluation of the Cryotherapy in the Prevention of Nails Toxicity Induced by Taxotere® in Breast or Prostate Cancer

Phase 3

Completed

• Conditions: Breast Neoplasms; Prostate Cancer; Nail Diseases
• Interventions: Procedure: Frozen Glove

• Registration Number: NCT00925418
• Lead Sponsor: Institut Paoli-Calmettes

Brief Summary

Taxotere® can induce nails changes like dyschromia, hematoma, lines of Beau-Reil (signing the stop of the epithelial proliferation), abscess, or pain. In this context, this randomized, monocentric phase III trial evaluates the cryotherapy, using frozen glove, in the prevention of nails toxicity induced by Taxotere® in patient treated for breast or prostate cancer.

Primary objective:

Demonstrate a reduction of the nails toxicity using frozen glove during chemotherapy with Taxotere®.

Secondary objectives:

Analysis of time of protection against onycholysis Estimation of the efficiency of cryotherapy, and impact on quality of life Tolerance and compliance of the frozen glove

Detailed Description

Not available

Study Timeline

• Study Start: 2006-09
• Study First Submitted: 2009-06-19
• Study First Submitted QC: 2009-06-19
• Study First Posted: 2009-06-22
• Primary Completion: 2010-09
• Study Completion: 2011-07
• Status Verified: 2011-09
• Last Update Submitted: 2011-09-13
• Last Update Posted: 2011-09-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 168

Inclusion Criteria

• Patients with hormono-resistant breast cancer or metastatic prostate cancer treated by chemotherapy with Taxotere®.
• Patients aged 18 and older
• Nail toxicity < grade 2 (CTC-AE version 3.0)
• Informed patients with signed consent

Exclusion Criteria

• History of treatment with taxane
• Raynaud syndrome
• Distal metastasis in superior extremity
• Nail diseases
• Distal arteriopathy
• Cold intolerance
• Peripheral neuropathy>=2
• Pregnancy, breast feeding
• Unable to give informed consent
• Unable to have a medical follow-up for social, geographical, family or psychological reasons

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
With Glove	Frozen Glove	Patients use frozen glove during chemotherapy with Taxotere®

Primary Outcome Measures

Name	Time	Method
Number of patients treated by Taxotere® with nail toxicity >= 2 (CTC-AE version 3.0)	4 months

Secondary Outcome Measures

Name	Time	Method
Number of day between inclusion and apparition of nail toxicity	4 months
Necessity of local care, existence of pains	4 months
Tolerance and compliance for the frozen glove	4 months

Trial Locations

Locations (1)

Institut PAOLI-CALMETTES; 🇫🇷 Marseille, France